A single ascending dose study of AX-024.HCl in healthy male volunteers
Research type
Research Study
Full title
A Randomized, Placebo Controlled, Double Blind, Dose Escalating, Crossover, Safety and Pharmacokinetic Study of AX-024.HCl in Healthy Male Subjects.
IRAS ID
159557
Contact name
Girish Sharma
Contact email
Eudract number
2014-002162-80
Research summary
AX-024.HCl has been developed to treat autoimmune diseases such as Asthma. AX-024.HCl works differently to most current treatments as it is not an immunosuppressant. Most current treatments suppress the immune system and although this has a positive effect on the person suffering from an autoimmune disease, it also leaves the person very vulnerable due to the fact the immune system is not performing optimally.
This study has a sentinel design, thus 2 dose leaders will be administered AX-024.HCl or placebo 24 hours prior to the remaining subjects (1 Active: 1 Placebo). The study consists of 2 cohorts, within each cohort there are subjects.
The study also adopts an alternating panel design, meaning individual subjects will undergo a total of 3 treatment periods (Dose levels). Altogether the study encompasses 6 treatment periods. In between each treatment period there will be a dose escalation review meeting where the PK results and safety data from the previous treatment period will be reviewed.
Subjects will attend simbec on Day -1 and leave on the morning of Day 4 (72 hours post dose).
The main objective is to determine the safety of single ascending doses of AX-024.HCl in healthy male subjects. The study will also assess the PK.
The population who are eligible to take part in the study are healthy male, non-smoking volunteers, aged between 18 and 55 years,as determined by screening tests at Simbec.
Participation in the trial will last for about 12 weeks (from first screening visit to final post study visit).
REC name
Wales REC 2
REC reference
14/WA/1045
Date of REC Opinion
29 Jul 2014
REC opinion
Further Information Favourable Opinion